Sanofi Pasteur recommends Dengvaxia only to people with prior dengue infection

Drug manufacturer Sanofi Pasteur on Thursday acknowledged the study by the New England Journal of Medicine that affirmed the increased risk of severe dengue posed by the anti-dengue vaccine Dengvaxia on people who had previously received shots.

"In this supplementary analysis, we found an increased incidence of severe disease in vaccinated people without a prior infection compared to unvaccinated people without a prior infection," Sanofi Pasteur said in a statement.

The firm also said vaccinated individuals without prior infection had the same risk factor of getting severe dengue from a mosquito bite as unvaccinated persons who get a secondary infection.

"More importantly, the degree of severity of the disease in vaccinated individuals responded well to medical care and all individuals recovered fully," the company said.

On the other hand, Sanofi said the New England study reinforced Dengvaxia's efficacy in preventing dengue on individuals who already have a history of dengue.

"This new publication confirms the vaccine’s potential to prevent dengue, particularly severe dengue (84%) and hospitalizations due to dengue (80%) for the 5-year follow-up period of the study in individuals 9 years of age or older who have had a  prior dengue infection," it wrote.

The study recognized effects already found in a prior study by the World Health Organization's Strategic Advisory Group of Experts on Immunization on Dengvaxia.

Sanofi Pasteur emphasized that it has reached out to national regulatory authorities in countries where Dengvaxia was distributed since it initially revealed the vaccine's possible ill effects in November 2017.

In the process, the company said it realized "the increasing importance of being able to communicate complex science in an understandable way to avoid unnecessary anxiety and correct any misunderstanding in the public about the safety or efficacy of our vaccines."

Earlier this year, the Department of Health filed a case against Sanofi Pasteur over its non-disclosure of Dengvaxia's possible side-effects.

Sanofi Pasteur denied negligence in communicating the effects of the anti-dengue vaccine, but agreed to refund all of the doses used in the government's dengue vaccination program. — MDM, GMA News